A. T. 10
Producer: Nycomed Austria GmbH (Nikomed Austria Gmbh) Austria
Code of automatic telephone exchange: A11CC02
Release form: Liquid dosage forms. Solution for intake.
General characteristics. Structure:
Active agent: Dihydrotachysterolum - 1,0 mg
Auxiliary components: Triglycerides with an average length of a chain.
Description: transparent, slightly yellowish, Solutio oleosa.
Dihydrotachysterolum on a chemical structure and the mechanism of action is close to D2 vitamin, is D3 provitamin, by efficiency is similar to calcitriol (difference only in time of approach of effect). At hypofunction of epithelial bodies increases concentration of calcium in plasma due to increase in its absorption in intestines (to a lesser extent, than ergocalciferol) and strengthenings of its transport from a bone tissue (in high doses), strengthens mobilization of phosphorus from organic compounds of a bone and removal by his kidneys, reduces activity of the alkaline phosphatase (AP), stabilizes concentration of calcium and connects it in a bone tissue, preventing osteoporosis at disturbance of calcium-phosphorus exchange. Possesses weak (in comparison with ergocalciferol or kolekaltsiferoly) antirachitic activity. Use without tolerance development is possible for a long time.
Pharmacokinetics. Absorption - bystry, in distal department of a small intestine. In blood contacts alpha globulins. It is deposited generally in a liver and fatty tissue.
25 hydroxydihydrotachysterolums are metabolized in a liver before formation of an active metabolite. It is removed with bile and through kidneys.
Indications to use:
• Hypoparathyrosis (idiopathic and postoperative)
Route of administration and doses:
The daily dose is defined by the doctor individually, depending on calcium level in blood. 0.5 the mg of the drug A.T.10 corresponds to about 15 drops. The recommended doses make:
At a hypoparathyrosis - on 0.75-2.5 mg/days within several days, a maintenance dose - 0.2-1 mg/days.
A.T.10 solution can be accepted inside on an empty stomach or after food with a small amount of liquid, it is possible with food (for example, on a piece of bread or sugar); Solutio oleosa does not mix up with water. The daily dose of drug can be accepted in stages. Duration of treatment is defined by the doctor.
Treatment by the drug A.T.10 cannot be interrupted independently.
Features of use:
Treatment should be carried out under control of content of calcium and phosphorus to blood (before treatment, in 5-7 days from an initiation of treatment and then 1-2 times a month).
It is recommended to adhere to a diet with high content in food of calcium and low - phosphorus.
At appointment during pregnancy in high doses development of premature closing of seams and fontanels in a fruit is possible.
Effect of drug can remain about one month after its cancellation. 1 mg of Dihydrotachysterolum is equivalent to 3 mg (120 thousand ME) of ergocalciferol.
As drug has narrow therapeutic width, concentration in blood of calcium, phosphates, creatinine, an urea nitrogen, activity of ShchF should be defined at first once a week, then - periodically during the entire period of administration of drug in therapeutic doses. The index is recommended to define calcium/creatinine each 1-3 months up to stabilization of a condition of the patient. Concentration of calcium in blood should not exceed 8.8-10.3 mg / 100 ml. The indicator of the work of concentration of calcium on concentration of phosphates (Sa x P) should not exceed 60 mg/dl.
Each 3 months it is necessary to conduct X-ray inspection of bone system.
Interaction with other medicines:
Vitamin D, thiazide diuretics, calcium drugs, adrenostimulyator, parathyroid hormone strengthen a hypercalcemia.
At simultaneous treatment by thyroxine after cancellation of the last development of a hypercalcemia is possible.
Blockers of "slow" calcium channels, beta adrenoblockers, weaken effect.
The combination with Fenoterolum is not recommended.
At a hypervitaminosis strengthening of effect of cardiac glycosides and increase in risk of developing of the arrhythmia caused by development of a hypercalcemia is possible (dose adjustment of cardiac glycoside is reasonable).
Under the influence of barbiturates (including phenobarbital), Phenytoinum and Primidonum the need for Dihydrotachysterolum can increase considerably that is expressed in strengthening of osteomalacy or severity of rickets (it is caused by acceleration of metabolism of Dihydrotachysterolum in inactive metabolites owing to induction of microsomal enzymes).
Long therapy by drug against the background of simultaneous use aluminum - and magnesium - the containing antacids increases its concentration in blood and risk of developing of intoxication (especially in the presence of a chronic renal failure).
The calcitonin, derivatives of etidronovy and pamidronovy acids, пликамицин, gallium nitrate and glucocorticosteroids reduce effect.
Colestyraminum, колестипол and mineral oils reduce absorption in a GIT of fat-soluble vitamins and demand increase in their dosage.
Increases absorption of phosphorus drugs and risk of emergence of a hyperphosphatemia.
Simultaneous use with other analogs of vitamin D (especially kaltsifedioly) increases risk of development of a hypervitaminosis it (is not recommended).
• Hypersensitivity to vitamin D drugs
• Hypervitaminosis D
• A renal osteodystrophy with a hyperphosphatemia
• The muscular spasms which developed owing to a hyperventilation (a hyper ventilating tetany)
With care - atherosclerosis, a pulmonary tuberculosis (an active form), chronic cordial недостаточнгсть, a hyperphosphatemia, phosphatic нефроуролитиаз, a chronic renal failure, a sarcoidosis or other granulomatoses, pregnancy, the breastfeeding period, advanced age (can promote development of atherosclerosis), children's age.
Use at pregnancy and during breastfeeding
Dihydrotachysterolum in insignificant quantities gets through a placental barrier and into breast milk. A.T.10 can be appointed pregnant according to vital indications in case of the hypocalcemia caused by a hypoparathyrosis and uncontrollable reception only of calcium drugs. At the same time control of concentration of calcium has to be carried out to blood.
At overdose development of a hypercalcemia is possible. Hypercalcemia symptoms: appetite loss, nausea, vomiting, diarrhea or lock, abdominal pain, increase in arterial pressure, polyuria, thirst, fatigue, muscular weakness, disorientation, drowsiness, pallor of integuments, headache, heartbeat. In this case administration of drug should be stopped and defined concentration of calcium in blood.
Long increase in level of calcium in blood can lead to a renal failure, development of an urolithiasis and calcification of soft tissues and kidneys. The specific antidote at overdose of A.T.10 does not exist. Treatment of a hypercalcemia is carried out by an artificial diuresis using loopback diuretics, purpose of a bezkaltsiyevy diet, glucocorticosteroids, bisfosfonat and a calcitonin.
In case of emergency (giperkaltsiyemichesky crisis) or at patients with a renal failure, carry out a hemodialysis for decrease in serumal concentration of calcium.
After normalization of content of calcium in blood, administration of drug it is necessary to renew and modify a dose.
Period of validity of 5 years. Not to use after a period of validity. In protected from light and the place, unavailable to children, at a temperature of 18-25 °C.
According to the recipe
Solution for intake 1mg/ml.
On 15 ml of solution in a glass bottle of light-protective glass with the screw-on stopper under which there is a stopper dropper together with the application instruction place in a cardboard pack.